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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION REVACLEAR 300 DIALYZER DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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BAXTER HEALTHCARE CORPORATION REVACLEAR 300 DIALYZER DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 300
Device Problem Leak/Splash (1354)
Patient Problem Insufficient Information (4580)
Event Date 02/21/2022
Event Type  malfunction  
Event Description
The patient was started on the machine and within about 1-2 minutes there was a blood leak alarm. Blood was seen in the arterial coupling as well. We did a blood leak test strip which was positive.
 
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Brand NameREVACLEAR 300 DIALYZER
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
one baxter parkway
deerfield IL 60015
MDR Report Key13720070
MDR Text Key286937750
Report Number13720070
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/24/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number300
Device Catalogue Number114745L
Device Lot NumberC621304907
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/24/2022
Event Location Outpatient Treatment Facility
Date Report to Manufacturer03/10/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Unkown

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